Experimental Pilot Trial Assessing Static Graviceptive Function in Patients With Cervical Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Subjective visual vertical (SVV), measured in degree (°)
研究概览
简要总结
The purpose of this experimental pilot study is to test the effect of normalization of the head position on the sense of balance at patients with cervical dystonia under routine botulinum toxin treatment.
详细描述
Background:
The pathophysiological mechanism of cervical dystonia remains unclear. Affection of static graviceptive function has been shown in these patients by measuring the Subjective Visual Vertical (SVV). Healthy subjects, tested with voluntary head tilt, would tilt SVV in the opposite direction of the head. (Müller "E" effect), whereas patients with cervical dystonia set SVV close to true upright with a minimal deviation toward head-tilt. The mechanism of this change in otolith activity in patients with cervical dystonia is still unknown. When treated with botulinum toxin, head deviation will be reversed during a period of approximate 6-9 weeks, with a first peak of action after approximate 3 weeks.
Aim
The aim of this study is to investigate the effect of normalization of the head position under routine intramuscular botulinum toxin application in the cervical muscles (screening, 3 weeks and 9 weeks after injection) on static graviceptive function in patients with cervical dystonia.
Rationale
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Idiopathic CD and willing to participate on the study,
- •Isolated laterocollis or laterocollis and torticollis with maximum of 15°rotation
- •Aged 18-80 years,
- •Under routine treatment with botulinum toxin
排除标准
- •Patients and Control
- •History of vestibular disorders
- •Torticollis with >15°rotation
- •Secondary CD (structural MRI lesions, Mb. Wilson)
- •Contraindication for intramuscular botulinum toxin therapy: bleeding disorder or anticoagulation therapy
结局指标
主要结局
Subjective visual vertical (SVV), measured in degree (°)
时间窗: screening
Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck. For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint. In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device. Patients adjust bar for parallel alignment with the perceived gravitational vertical. The operator tilts the bar in a random order 18° from the physical vertical.
SVV in degree (°)
时间窗: 9 weeks after screening
Assessment: sitting upright in dark room, head is fixed using a head holder with a strap and a neck rest covering the occiput and posterior neck. For deviation of head (0°, 15° and 30° to the left and right side), head holder can be rotated about its midpoint. In front of patient (distance of 100 cm) is dim light bar, which can be rotated about its midpoint by means of an electronic motor and a remote control device. Patients adjust bar for parallel alignment with the perceived gravitational vertical. The operator tilts the bar in a random order 18° from the physical vertical.
次要结局
- Degree of head deviation (°)(screening)
- degree of head deviation (°)(9 weeks after screening)
研究者
Kirsten Elwischger
MD
Medical University of Vienna